Sprayed opaque bandage composition



United States Patent 3,476,853 SPRAYED OPAQUE BANDAGE COMPOSITEON Bernard Jatul, North Caldwell, and Christopher Costello,

Summit, N.J., assignors to Colgate-Palmolive Company, New York, N.Y., a corporation of Delaware No Drawing. Filed Apr. 13, 1965, Ser. No. 447,870 Int. Cl. Afilf 15/00; A6lk 27/00 US. Cl. 42445 1 Claim ABSTRACT OF THE DISCLOSURE A sprayable composition for use as a dressing including a film-forming material, an opacifying material, at least one medicament, a solvent and a gaseous propellent.

The present invention relates to the application to the skin by spraying of an opacifying agent in a solution of at least one film-forming polymer, at least one plasticizer and a propellant or mixture of propellants. For the treatment of such topical injuries as bruises, abrasions, minor cuts, nonpoisonous insect bites, plant dermatitis and minor burns, it is preferred to incorporate in the aforedescribed fluid dressing at least one therapeutic agent such as a local anesthetic, an antiseptic, an ischemic agent, and an agent to promote epithelization. Presently it is preferred to apply the fluid dressing or bandage by spraying the fluid dressing comprising an opacifying agent, a film-forming polymer, a plasticizer, and one or more therapeutic agents from a closed pressure-resistant container by the expansion of normally gaseous propellant in liquid state. The therapeutic agent or agents incorporated in the film-forming vehicle is, or are, correlated with the use to which the fluid dressing or bandage is to be applied.

The present invention provides a means of applying a protective opaque film which is immediately dry to the touch when applied from a distance of four (4) to six (6) inches, which is water-resistant yet conveniently removable by moderate rubbing under water, is non-stinging, does not interfere with water diffusion from the skin, does not interfere with the normal healing process, and does not interfere with skin respiration. The present invention provides a simulated bandage which is flexible, opaque, porous, protective and adhering to the skin.

Upon application to abrasions so induced in the skin of rabbits as to cause seepage of blood, it was shown to staunch bleeding promptly and to aflord a protective film. In wound strength studies on rats, it does not appear to alter the normal healing process. By radioactive techniques, it has been shown, in human in vivo studies, that the protective film of the present invention does not alter normal water difiusion from the skin. It does not alter skin respiration in the mouse and guinea pig. The diffusion of antiseptic agents from the dressing was shown by bacteriological tests and diffusion of local anesthetic was shown by pharmacological tests. Thus, the present invention provides a bandage or dressing which satisfies all of the requirements of the conventional bandage or dressing but which can be applied expeditiously.

The present novel immediately drying opaque sprayable bandage or dressing comprises an antiseptic moiety, an opacifying ingredient or ingredients, one or more local anesthetics, a vasoconstrictor employed as an ischemic agent, at least one film-forming polymeric component, at least one plasticizer, at least one opacifying agent, solvents and propellants. An antihistamine can also be employed as an antipruritic and antiallergic agent. Illustrative of the members of each of the aforementioned classes of constituents of the novel bandage or dressing of the present invention are the following:

ANTISEPTICS Sodium ethylmercurithiosalicylic acid (Thimerosal);

Patented Nov. 4, 1969 octyl cresoxy ethoxy ethyl dimethyl benzyl ammonium chloride (Hyamine 10X); N-(trichloromethylthio)-4-cyclohexene-l,Z-dicarboximide (Vancide 89 RE); a mixture of 5,4'-dibromosalicylanilide and 3,5,4-tribromosalicylamilide (Diaphene); phenylethyl alcohol; sodium dehydroacetate; butyl parahydioxybenzoate (Butyl para ben); benzyl paral'lydroxybenzoate (Benzyl paraben); 2,2-thiobis(4,6-dichlorophenol) or bithionol; trichlorocarbanilide or 3,4,4-trichlorocarbanilide; a mixture of polybrominated salicylanilides available from Fine Organics Inc., Lodi, NJ. as Temosept; methyl thiram, i.e., tetramethylthiuram disulfide; chlorobutanol; a mixture of alkyldimethylbenzylammonium chlorides of the general formula C H CH N( CH RC1 in which R represents a mixture of alkyl groups having eight to eighteen (inclusive) carbon atoms, i.e., C H to C T-I and presently available as Zephiran Chloride; and benzyl alcohol.

LOCAL ANESTHETICS 4- [3- (p-butoxyphenoxy) propyl] morpholine hydrochloride (Pramoxine HCl); ethylaminobenzoate; and butylaminobenzoate.

VASOCONSTRICTORS (EMPLOYED AS ISCHEMIC AGENTS) Methyl benzethonium chloride, Sodium ethylmercurithiosalicylic acid (Thimerosal), 2-aminoheptane carbonate, and phenylephrine H Cl.

ANTIBACTERIAL AGENTS Neomycin; tryothricin; and gramicidin.

OPACIFYING AGENTS A starch derivative which is a free flowing ungelatinized starch derivative comprising the product of an ungelatinized starch acid-ester of a substituted dicarboxylic acid of the following formula wherein R is a radical from the group diethylene and trimethylene radicals and R is a hydrocarbon substituent from the class consisting of an alkyl, alkenyl, aralkyl, and aralkenyl reacted with a compound containing a polyvalent metal ion and available under the trade name Dry- Flo starch from National Starch Products, Inc., calamine, micronized cellulose, titanium dioxide, magnesium stearate, stearic acid, zinc oxide and silica.

FILM-FORMING POLYMERIC COMPONENTS Ethyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, polyvinyl alcohol-polyvinyl pyrrolidone copoymer, carboxylated copolymer of vinyl acetate, isobutylmethacrylate, polyvinyl acetate, and carboxymethyl cellulose; Dicrylan 405 and 394 available from Ciba Company, New York, N.Y., and said to be acrylic copolymers such as described in U.S. Patents Nos. 2,897,172 and 3,025,219.

PLASTTCIZERS leyl alcohol, polyoxyethylene sorbitan monolaurate (Tween 20); a composition of matter available from Malmstrom Chemical Corporation under the trade name of Lantrol, being described in US. Patent No. 2,758,- and said to be a mixture of unaltered oil-soluble esters separated from the higher waxy ester of lanolin by a solvent crystallization process; hydrogenated castor oil (Castorwax); isopropyl myristate, cetyl alcohol, and camphor.

SOLVENTS Methanol, dichloromethane, trichloromonofluoromethane, dichlorodifluoromethane.

3 ANTIPRURITIC AND ANTIALLERGIC AGENTS Antihistamine, e.g., methapyriline fnmarate.

PROPELLANTS Fluorochlorohydrocarbons such as Freon and vinyl chloride.

The concept of eliminating textile bandages is several years old as is evident from the disclosure of US. Patent No. 2,801,201 in which a composition for the treatment an injured surface of living tissue from a distance of 4 to 6 inches comprising up to about 0.1 percent sodium ethylmercurithiosalicylic acid, about 1 percent ethyl aminobenzoate, between about 0.53 and 1.6 percent ethyl cellulose, between about 0.02 and 0.08 percent silica having a micron size of about 0.02, about 6.7 to percent dichloromethane, up to about 1 percent polyoxyethylenc sorbitan monolaurate, between about 2.7 and 8 percent of a starch derivative comprising the product of an unof burns adapted to be dispensed from pressure packaged 10 gelatinized starch acid-ester of a substituted dicarboxylic dispensers is described. In US. Patent No. 2,804,073 a 391d of the following formula fluid surgical dressing and, more particularly, a transparent releasably adhesive dressing to be applied as a liquid or spray is disclosed. A self-propelling medicinal ointment Starch-OOC-RCOOH comprising mineral oil containing dispersed polyethylene resin and a volatile propellent is described in US. Patent e ein R is a radical from the group diethylene and tri- No. 3,079,299. However, none of the fluid dressings or methylene radicals and R is a hydrocarbon substituent sprayable bandages combined in one formulation all of from the class consisting of alkyl, alkenyl, aralkyl, and the required characteristics that are found in the sprayable aralkenyl reacted with a compound containing a polydressing of the present invention. valent metal ion, and about 75 percent of a propellant Illustrative of a satisfactory sprayable dressing which is material of -60 percent trichloromonofiuoromethane immediately dry to the touch when applied from a distance and 6040 percent of dichlorodifiuoromethane, all perof about four (4) to about siX (6) inches is the following cents being expressed as percents by weight based upon formulation: the weight of the final composition.

Percent by Weight Ingredient Broad Specific Ingred. No.:

1 Sodium ethylmercurithiosalicylic acid 0 01-0. 1 0.01 2 Ethylaminobenzoate 1.00 3... Ethyl cellulose .53-1. 1.00 4 Silica 0.02 micron 0 02-008 0.04 5 Oamphor 0.16 6. Methanol 2. 13 7 Dichloromethane 6.7-10.0 10.00 8... Polyoxyethylene sorbltan monolaurate .11.0 0.20 9... Dri-F10Starc 2. 67-80 8.00 10.- D and 0 Red #18 0. 0013 11.. D and 0 Yellow #11 0. 002 12.. D and C Green #6 0.0003 13 Trichloromonofluoromethane 40-60 38.7282 14 Dichlorodifiuoromethane 60-40 38. 7282 Hercules N50. H Compatible colors. Cab-O-Sil M5. See opacifying agents, supra.

The sprayable dressing was prepared by milling ingl'e- References Cited dlent 4 into a portion of 7. lngredlents l, 2, 5, 8, 10, ll UNITED STATES PATENTS and 12 were dissolved in a mixture of the balance of 7 and 6. The suspension of 4 was then blended into the afore- 2,481,419 1949 Hamilton 167-84 Said solution. To this mixture the trichloromonofluoro- 2,693,438 2/1951 7-434 methane (ingredient 13) Was added. Ingredients 3 and 9 2,801,201 7/1957 KIPHIS 1 -8 are then added to the mixture in an aerosol container and 2,804,073 8/ 1957 Galbenne 784 the container sealed with a valve. The container is Shaken 3,073,794 1963 t n l 16784 to dissolve 3 and suspend 9. The dichlorodifluoromethane was then added through the valve and the contents of the aerosol container shaken.

What is claimed is:

1. A pressurized composition in an aerosol container and adapted to form a spray upon the release of pressure therefrom which spray forms a protective opaque film which is immediately dry to the touch when applied to OTHER REFERENCES Washington Post, page 64, Nov. 18, 1952, Cosmetics, Science and Technology.

Sagarin (1957), pp. 231 233.

ALBERT T. MEYERS, Primary Examiner STANLEY J. FRIEDMAN, Assistant Examiner 

